Automatic surgical sponge counter and blood loss determination system

ABSTRACT

A surgical sponge detection system includes a device for automatically counting soiled surgical sponges which includes a reader which scans each sponge entered and determines sponge type from a tag affixed to each sponge and a control unit which processes data received from reader contained within sponges entered. The reader includes a non-optical scanner means which can read an indicating means on the sponges even when the indicating means is covered with blood or other body fluids.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 13/324,190, filed Dec. 13, 2011, and entitled “AutomaticSurgical Sponge Counter and Blood Loss Determination System,” which is acontinuation of U.S. patent application Ser. No. 11/248,350, filed Oct.12, 2005, and entitled “Automatic Surgical Sponge Counter and Blood LossDetermination System,” which is a divisional of U.S. patent applicationSer. No. 10/411,885, filed Apr. 11, 2003, now U.S. Pat. No. 6,998,541,which is a continuation-in-part of U.S. patent application Ser. No.09/304,881, filed May 4, 1999, which is a continuation-in-part of U.S.patent application Ser. No. 08/833,387, filed Apr. 4, 1997, now U.S.Pat. No. 5,923,001, which is a continuation-in-part of InternationalApplication No. PCT/US1995/09094, filed Jul. 19, 1995, which is acontinuation of U.S. patent application Ser. No. 08/286,413, filed Aug.5, 1994, now U.S. Pat. No. 5,650,596, the entirety of all of which isherein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO A “MICROFICHE APPENDIX”

Not applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices which detect, collect, weighand count surgical sponges. The present invention also relates tosurgical sponges which can be detected non-optically.

2. General Background of the Invention

During surgery absorbent sponges are used to soak up blood and otherbody fluids in and around the incision site. Because the risk of asponge being retained inside a patient is so great, surgical personnelgo to great lengths to account for each and every sponge which is usedin surgery. Strict sponge count policies have been developed byhospitals to deal with this issue. Moreover, surgeons andanesthesiologists determine blood loss by using visual inspection or themanual weighing of soiled sponges, thus soiled sponges are usually keptin one area of the operating room. Another area of concern regardingsoiled surgical sponges is the risk of transmission of bloodbornediseases such as hepatitis B virus (HBV) and human immunodeficiencyvirus (HIV). To reduce exposure and contamination every precautionnecessary should be taken to reduce risk of infection.

Sponge counts are an essential part of operating room procedure. Theyhelp ensure patient safety by reducing the chance that a sponge will beretained inside of the patient. Typical sponge count policies include:an initial count at the beginning of a procedure and subsequent countsthroughout the procedure when additional sponges are added to thesterile field, before the closure of a deep incision, after the closureof a body cavity, when scrub or circulating personnel are relieved, andbefore the procedure is completed.

In addition, it is necessary for the anesthesiologist and surgeon tohave an accurate measurement of blood loss contained in sponges, so thatif excessive blood loss is occurring, blood components can be orderedand administered immediately. This information is provided by weighingsoiled sponges and then subtracting the dry weight of the number ofsponges weighed from the total.

Moreover, soiled sponges are a source of contamination, thus handlingand exposure should be kept to a minimum. Procedures which reduce thetransmission of bloodborne pathogens include making sure that soiledsponges are handled with gloves and instruments only and that usedsoiled sponges are appropriately contained and confuted.

In 1992, the Occupational Safety and Health Administration (OSHA) issuednew regulations regarding bloodborne pathogens in U.S. hospitals. Nearly6 million healthcare workers in the United States who could be“reasonably anticipated” to come in contact with blood and other bodyfluids are subject to the new regulations. These regulations areintended to reduce worker exposure to hepatitis B virus (HBV), humanimmunodeficiency virus (HIV), or other bloodborne pathogens. Under thesection on Engineering and Work Practice Controls, hospitals arerequired to eliminate or minimize employee exposure. This includes theimplementation of new designs for devices which count sutures andsponges.

For more information about surgical sponge handling and counting, pleasesee U.S. Pat. No. 4,422,548, incorporated herein by reference.

U.S. Pat. No. 3,367,431 discloses a device for automatically countingand weighing surgical sponges. However, the device cannot distinguishbetween different sponges. Also, the amount of blood contained in soiledsponges must be manually calculated. Further, it does not use removabledisposable bags.

U.S. Pat. No. 4,295,537 discloses a sponge-collecting device that keepscount and determines the weight of blood-soaked sponges. However, thedevice cannot automatically distinguish between different sponges. Also,the device does not automatically count the sponges (the number and dryweight of the sponges must be manually input).

U.S. Pat. No. 4,422,548 discloses a sponge-collecting device thatdetermines the weight of blood-soaked sponges. However, the devicecannot automatically distinguish between different types of sponges. Italso cannot determine the amount of blood in the sponges.

U.S. Pat. No. 5,009,275 discloses a sponge-collecting device thatdetermines the weight of blood-soaked sponges. However, the devicecannot automatically distinguish between different types of sponges, andso it cannot automatically determine the amount of blood loss whensponges of different dry weights are collected in the container.

Radio Frequency Identification Systems are based on two principlecomponents, a passive tag or transponder and a hand held or stationaryreader. In operation, the hand held or stationary reader emits a lowfrequency magnetic field, which activates the passive tag or transponderwithin its range. The passive tag has no power source of its own. Itderives the energy needed for operation from the magnetic fieldgenerated by the reader. Because the tags have no power source of theirown, the only limitation to the operational lifespan of the tag is thedurability of its protective encapsulation, usually, but not limited to,plastic or glass. Tags are available in many shapes and sizes, eachdesigned for the unique rigors and requirements of specificapplications. RF tags operate by proximity as opposed to optics like abar code. As a result they can be read in harsh environments, submergedin liquids and can be read spherically from any direction, through mostmaterials. They can be read through tissue, bone, etc.

Also of potential interest are the following U.S. Pat. Nos.:

3,367,431; 4,193,405; 4,498,076; 4,510,489; 4,658,818; 4,922,922;5,031,642; 5,057,095; 5,103,210; 5,188,126; 5,190,059; 5,300,120;5,329,944; 5,353,011; 5,357,240; 5,381,137; all patents cited in thefile of U.S. patent application Ser. No. 08/286,413.

SUMMARY OF THE INVENTION

The present invention involves the use of radio frequency identification(RF ID) tags on surgical sponges and two related medical devices whichwill be used to identify and track those sponges during surgery. RFtechnology was chosen by the present inventors because no othertechnology available offers the reliability, accuracy and performancedemanded by the operating room environment. The first device, ahand-held reader, will be passed over the surgical wound prior to theclosing of the wound by the surgeon. The hand-held reader will thenidentify any sponges which may have been inadvertently left in thewound, thus preventing the retention of sponges inside of the patient.This hand-held reader can be used during all surgical procedures andwill eliminate the dangerous and time consuming task of manuallycounting and bagging soiled sponges. The second device, a spongemanagement system including a counting, weighing, and calculating devicefor automatically counting and weighing surgical sponges and determiningthe amount of blood contained therein, will be utilized duringprocedures in which determination of blood contained in sponges isimportant. These procedures include; any procedure involving smallchildren or infants, and heavy blood loss procedures such ascardiovascular, transplants, and obstetrical. During surgery all soiledsponges, regardless of size, will be deposited into the counting,weighing, and calculating device where the device will then determinethe amount of blood contained in those sponges and display this amounton a liquid crystal display panel. In addition, the counting, weighing,and calculating device will automatically bag those sponges and give avisible running count of each type of sponge deposited. The hand-heldreader will be an attachment used with the counting, weighing, andcalculating device to be used at the time of closure to assure that asponge is not retained in the patient. The use of RF tagged sponges andthe accompanying identification systems discussed will have a tremendousimpact on operating rooms worldwide.

RF tags can also be attached to surgical instruments that mightaccidentally get left in the human body during surgery to allow thesesurgical instruments to be detected non-optically.

As used herein, “non-optical detection” means detection of an objectwithout visible light or X-rays. The preferred non-optical detectionmeans comprises radio frequency (RF) scanners.

The apparatus of the present invention solves the problems confronted inthe art in a simple and straightforward manner. What is provided is adevice which automatically counts surgical sponges and automaticallydetermines the amount of blood contained in the sponges, without anyinput or calculations during the surgery by any person. The apparatusincludes means for automatically determining the weight of the spongeswhen dry, and for deducting that weight from the total weight of thesponges and blood in the apparatus. The soiled sponges will be heldinside of the device in a removable disposable bag. Means are alsoprovided to keep a running total of the number of sponges which haveentered the apparatus from a predetermined time, and the total amount ofblood which has entered the device from a predetermined time, even whena full bag is removed and replaced with an empty bag in order to makeroom for additional sponges to enter the container.

The means for automatically determining the weight of the sponges whendry includes a non-optical scanner means which can read an indicatingmeans on the sponges even when the indicating means is covered withblood or other body fluids.

The present invention comprises a system for facilitating counting ofsurgical sponges and determining the approximate amount of body fluidscontained therein. It includes a plurality of sponges of varyingweights, each sponge having a dry weight before being used to absorbfluids and an indicating means thereon for preferably indicating thetype of sponge, the dry weight of the sponge, the dry weight of thesponge including the weight of the indicating means; and a device forcounting the surgical sponges and determining the approximate amount ofbody fluids contained therein. The device comprises a container meansfor containing the surgical sponges, the container means having anopening above a receptacle means for receiving the surgical sponges,scanner means for detecting when one of the surgical sponges has beendeposited into the device, and detecting means for automaticallydetermining the dry weight of the surgical sponges which have beendeposited into the device since a predetermined time by detecting theindicating means on the sponges. The device also includes calculatingmeans for automatically determining the approximate amount of body fluidcontained in the surgical sponges which have entered the container sincea predetermined time by subtracting the dry weight of the sponges fromthe weight of the sponges including the body fluids. The device furthercomprises first display means for displaying an indication of theapproximate amount of body fluid contained in the surgical sponges whichhave entered the container since a predetermined time, determining meansfor automatically determining the number of surgical sponges which haveentered the container since a predetermined time, and second displaymeans for displaying the number of surgical sponges which have enteredthe container since a predetermined time.

The detecting means is capable of distinguishing between multiple typesof surgical sponges (and preferably detecting multiple spongessimultaneously and identifying them) even those sponges of differenttypes but similar weights, and the second display means displays thenumber of each type of sponge which is received.

The first display means indicates, with an accuracy of +/−0.1%, theexact amount of body fluids contained in the sponges which have enteredthe container since a predetermined time.

The detecting means comprises a non-optical scanner means which can readan indicating means on the sponges even when the indicating means iscovered with blood or other body fluids.

The present invention includes apparatus for helping to prevent surgicalsponges from being inadvertently left in a patient after surgerycomprising a non-optical scanner means, a plurality of surgical sponges,and a plurality of identification tags, wherein each surgical sponge hasone of the identification tags securely attached thereto for allowingthe sponge to be detected by the non-optical scanner means, and eitherthe non-optical scanner means has means for detecting and identifyingmultiple identification tags simultaneously, or the tags can be encodedwith identifying means to identify the type of sponge to which it isattached, or both. Preferably, the identification tags do not exceed oneinch in diameter and 0.20 inches in thickness. The identification tagspreferably do not exceed four grams in weight, and more preferably donot exceed three grams in weight. Preferably, the identification tag isa radio frequency identification tag and the non-optical scanner meansis a radio frequency reader, the radio frequency reader preferably has aread range of at least 6 inches, more preferably at least 10 inches, andmost preferably at least 15 inches, when used with the identificationtags attached to the surgical sponges.

The present invention also includes a method of monitoring surgicalsponges during and after surgery for helping to prevent surgical spongesfrom being inadvertently left in a patient after surgery, comprising thefollowing steps:

using in a surgical wound only surgical sponges which each have anidentification tag securely attached thereto for allowing the sponge tobe detected by a non-optical scanner means;

using a non-optical scanner means to scan the surgical wound beforeclosing the surgical wound, wherein either the non-optical scanner meanshas means for detecting and identifying multiple identification tagssimultaneously, or the tags can be encoded with identifying means toidentify the type of sponge to which it is attached, or both.Preferably, the identification tags do not exceed one inch in diameterand 0.20 inches in thickness. The identification tags preferably do notexceed four grams in weight, and more preferably do not exceed threegrams in weight. Preferably, the identification tag is a radio frequencyidentification tag and the non-optical scanner means is a radiofrequency reader; the radio frequency reader preferably has a read rangeof at least 6 inches, more preferably at least 10 inches, and mostpreferably at least 15 inches, when used with the identification tagsattached to the surgical sponges.

The present invention also includes a system for facilitating detectionof surgical sponges, counting of surgical sponges and determining theapproximate amount of body fluids contained therein, comprising:

a plurality of sponges of varying weights, each sponge having a dryweight before being used to absorb fluids and an indicating meansthereon for indicating preferably the type of sponge, the dry weight ofthe sponge, the dry weight of the sponge including the weight of theindicating means;

a device for counting the surgical sponges and determining theapproximate amount of body fluids contained therein, comprising:

-   -   a container means for containing the surgical sponges,    -   an opening in the container means above a receptacle means for        receiving the surgical sponges;    -   scanner means for detecting when one of the surgical sponges has        been entered into the device;    -   detecting means for automatically determining the dry weight and        preferably the type of the surgical sponges which have entered        into the device since a predetermined time by detecting the        indicating means on the sponges;    -   calculating means for automatically determining the approximate        amount of body fluid contained in the surgical sponges which        have entered the container since a predetermined time by        subtracting the dry weight of the sponges from the weight of the        sponges including the body fluids;    -   first display means for displaying an indication of the        approximate amount of body fluid contained in the surgical        sponges which have entered the container since a predetermined        time;    -   determining means for automatically determining the number of        surgical sponges which have entered the container since a        predetermined time; and    -   second display means for displaying the number of surgical        sponges which have entered the container since a predetermined        time; and

a non-optical scanning means for detecting surgical spongesinadvertently left in a patient during surgery. Preferably, differenttypes of surgical sponges are received by the container, the detectingmeans is capable of distinguishing between multiple types of surgicalsponges, even those sponges of different types but similar weights, andthe second display means displays the number of each type of spongewhich is received. Preferably, the first display means indicates, withan accuracy of +/−0.1%, the exact amount of body fluids contained in thesponges which have entered the container since a predetermined time.Preferably, the detecting means comprises a non-optical scanner means.Preferably, the non-optical scanner means can read an indicating meanson the sponges even when the indicating means is covered with blood orother body fluids.

Preferably, the non-optical scanner means can simultaneously read,indicating means on all sponges within its read range and propertyidentify each sponge, and display the total number of sponges of eachtype.

It is object of the present invention to provide a system includingsurgical sponges which can be detected non-optically and a device whichwill detect these surgical sponges, regardless of size and location in apatient's body, during surgery with a high degree of accuracy.

It is another object of the present invention to provide a method ofdetecting surgical sponges non-optically, regardless of size andlocation in a patient's body, during surgery with a high degree ofaccuracy.

It is also an object of the present invention to provide a device whichwill detect surgical sponges, regardless of size and location in apatient's body, during surgery with a high degree of accuracy.

It is an object of the present invention to provide a device which willautomatically count surgical sponges, regardless of size, during surgerywith a high degree of accuracy.

It is a further object of the present invention to provide, in a deviceof this type, in addition to means for giving a running count ofsponges, means for simultaneously weighing sponges and instantly andaccurately calculating the amount of blood contained in those sponges.

Another object of the present invention is to provide a device whichcollects soiled surgical sponges and facilitates their disposal withminimal handling.

BRIEF DESCRIPTION OF THE DRAWINGS

For a further understanding of the nature, objects, and advantages ofthe present invention, reference should be had to the following detaileddescription, read in conjunction with the following drawings, whereinlike reference numerals denote Like elements and wherein:

FIG. 1 is a cutaway, side view of a first embodiment of the apparatus ofthe present invention;

FIG. 2 is a perspective view of the first embodiment of the apparatus ofthe present invention;

FIG. 3 is a detail of the control panel and display of the firstembodiment of the apparatus of the present invention;

FIG. 4 is a rear view of the first embodiment of the apparatus of thepresent invention;

FIG. 5 is a block diagram indicating the input and output of the CPU ofthe first embodiment of the apparatus of the present invention;

FIG. 6 is a top view of the first embodiment of the apparatus of thepresent invention;

FIG. 7 is a perspective view of the preferred embodiment of the presentinvention; and

FIG. 8 is a top view of the preferred embodiment of the method of thepresent invention.

PARTS LIST

The following is a list of suitable parts and materials for the variouselements of the preferred embodiment of the present invention.

-   1 identification tag (indicating means) on sponge 2-   2 sponge-   3 opening in apparatus 30 for sponges 2-   4 control unit (CPU)-   5 display panel-   6 reader (antenna)-   7 reader electronics-   8 disposable bag-   9 door-   10 weighing scale-   11 rechargeable battery-   12 shelf for extra bags 8-   13 wheels-   14 retractable electrical cord-   15 wiring interconnecting the reader electronics 7 and the reader 6-   16 wiring interconnecting the reader electronics 7 and the control    unit 4-   17 wiring interconnecting the reader electronics 7 and the battery    11-   18 wiring interconnecting the control unit 4 and the scale 10-   19 wiring interconnecting the battery 11 and the scale 10-   20 wiring interconnecting the battery 11 and the control unit 4-   21 bag container-   22 handle for door 9-   23 radio waves-   30 automatic surgical sponge counter and blood loss determination    apparatus-   31 sloped sides of receptacle 32-   32 receptacle-   33 label-   34 receptacle lid-   35 reed switch (preferably magnetic)-   36 electronically controlled latching mechanism-   40 hand-held RF reader (LanLink Corporation, Advanced Long Range    Reader or Trovan Model LID 500, for example)-   41 red indicator light on reader 40-   42 green indicator light on reader 40-   43 LCD (liquid crystal display) readout on reader 40-   44 antenna of reader 40-   45 power trigger of reader 40-   51 sponge type and quantity display screen-   52 blood-loss display screen-   53 battery charge indicator.-   54 on-off switch-   55 alarm light-   56 hold button-   80 surgical site-   81 wound-   82 patient-   85 surgeon

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The first embodiment of the present invention, automatic surgical spongecounter and blood loss determination apparatus 30, is shown in FIGS. 1through 5.

The device (See FIG. 1) takes the place of a kickbucket which is now inuse in operating rooms around the world. It is mobile (mounted on wheels13, powered by rechargeable battery 11), compact in size (30″×18″×18″,for example) and easy to operate. During an operation all surgicalsponges 2 are deposited into the apparatus 30 by dropping them into areceptacle 32 having sloped sides 31 leading to an opening 3 at the topof apparatus 30. Receptacle 32 preferably has dimensions of 15″ by 16″,more preferably has dimensions of 16″ by 18″, and most preferably hasdimensions of 18″ by 18″. The top of receptacle 32 is preferably about20-40″ above the floor, more preferably about 25-35″ above the floor,and most preferably about 30″ above the floor. Opening 3 preferably hasdimensions of from 4″ by 5½″ to 6½″ by 8½″, and more preferably hasdimensions of 5½″ by 7″.

To increase the chance that a sponge tossed at the apparatus of thepresent invention will land in receptacle 32, receptacle 32 ispreferably rather large. To reduce evaporation from bag 8, opening 3 ispreferably relatively small. Preferably, the ratio of the size ofopening 3 to the size of receptacle 32 is rather small.

When sponge 2 passes through the opening 3 and falls into bag 8, areader 6 interrogates the radio frequency identification tag 1 attachedto sponge 2 and determines from the unique identification code on thetag what type of a sponge (Lap, Mini-Lap, Raytec, etc.) has entered thecontainer. Control unit 4 is preferably programmed with all of theunique codes associated with different types, sizes and brands ofsurgical sponges. In addition, Control unit 4 is preferably programmedwith the corresponding dry weight for each unique code. The control unit4 receives data from the reader 6 along with data from the scale 10 andthen processes this information. The final output is displayed on thedisplay panel 5: a readout of the number of sponges contained in theunit, broken down by type, is displayed on screen 51; the amount ofblood and other bodily fluids contained in the sponges is displayed(preferably in cubic centimeters) on screen 52. This amount will becalculated by the control unit 4 using a formula based on the weight ofthe sponges 2 soiled, minus the weight of the sponges 2 dry (differentsize sponges 2 have different dry weights; the dry weights of differentsponges are preferably programmed into the software so that nurses willno longer have to do this manually).

The battery charge is indicated on battery charge indicator 53, with theleft side being red and lighting up if the charge is low, and with theright side being green and lighting up if the charge is sufficient. Anon-off switch 54 lights up with a green light when the power is on.

Label 33 displays the symbols and explanations for a number of alarmconditions which cause alarm light 55 to light up. When one of theconditions displayed on label 33 occurs, the appropriate symbol flashesin screen 51. The conditions include a low battery charge condition, ajammed door, a full bag, open receptacle lid, close receptacle lid, opendoor, close door and the presence of foreign objects (needles, hypos,cottonoids, bovie tips, etc.) inside of the device.

Sponge 2 is deposited in a disposable bag 8 which is suspended in a bagcontainer 21 mounted to a scale 10. The scale 10 weighs the contents ofbag 8 and sends this data to the control unit 4 as mentioned above to beprocessed. Apparatus 30 can be programmed to alarm once a predeterminednumber of sponges 2 has been reached or when the bag 8 is full. Tochange bag 8, the operator of apparatus should depress hold button 56.Once hold button is depressed, the display panel will prompt operator toclose receptacle lid 34 and simultaneously unlock the electroniclatching mechanism 36. The disposable bag 8 can then be removed througha rear door 9 and replaced with a new bag 8. A compartment 12 to storeextra bags is provided. To resume operation, door 9 must be closed. Oncehold button 56 is released, the electronic latching mechanism 36 islocked and operator will be prompted to open receptacle lid 34. The holdprocedure will prevent sponges from being deposited accidentally whenthere is no bag in the device and the locked door will prevent personnelfrom opening the device when in operation. A reed switch 35 indicates tothe Control Unit 4 if receptacle lid 34 is open or shut. The memory ofcontrol unit 4 will continue to give a running count of sponges 2 aswell as estimated blood loss amount for the duration of the entiresurgical procedure. Once the operation is complete and all counts havebeen verified, the device 30 can be cleaned very easily, reset and readyfor the next case. Because of the small size and mobility of apparatus30, it can be moved from room to room effortlessly.

Tags 1 can preferably endure temperatures of up to about 400 degreesFahrenheit (about 200 degrees Centigrade) to allow them to beautoclaved.

At the end of the day the device 30 can be plugged with plug 14 into anelectrical outlet and recharged for the next day's use. Additionalfeatures can include: a gauge which indicates battery status bydisplaying the remaining life of the battery in hours and a low batteryalert alarm. The battery 11 is rechargeable during operation of thedevice 30.

While other technologies may be available, radio frequency is believedto be the optimal technology. Radio frequency tags are preferred toother identifying means because they do not depend upon light fordetection—they can be detected even when completely covered with blood.Other identifying means which can be attached to surgical sponges andwhich does not depend upon light for detection could be used.

The preferred tag to use with the present invention is the Sokymat, SA,PICCOLO-TAG. This RFID tag has a operating frequency of 125 khz, 64 bitsof memory, a diameter of 10 mm and thickness of 2 mm. The preferredreader 6 is the LAN-Link Corporation—Advanced Long Range Reader, with acustomized antenna with dimensions of nine inches by nine inches. Thetag 1 is preferably attached to a surgical sponge by being sewn onto thesponge with and where the radio opaque marker is currently attached. Theinformation which tag 1 contains is preferably simply a number, acollection of numbers, or a combination of numbers and letters. The tagspreferably store up to at least 32 binary bits of data, and morepreferably at least 64 binary bits of data Current commerciallyavailable tags can store up to 1,000 binary bits of data.—These tags canbe programmed so that certain bits in the data string can be dedicated.For example, all tags which will be attached to Laparotomy sponges of aparticular size, a particular dry weight and are manufactured by aparticular company will have the same code in the dedicated portion ofthe data string. Control unit 4 will store all of the unique codesassociated with different types, sizes and brands of surgical sponges.In addition, Control unit 4 will store a corresponding dry weight foreach unique code.

Advantages of the Device of the Present Invention

The sponge count is an essential part of operating room procedure. Itnot only assures patient safety, but it also provides the medical teamwith an ongoing estimation of blood loss. Current methods for handlingsurgical sponges are antiquated and inadequate in today's modern andpotentially dangerous operating room environment. Even in the newesthospitals, sponges are still counted and weighed manually. Theseprocedures are time-consuming, prone to human error and unnecessarilyexpose medical staff to blood contact. The present invention addressesthese shortcomings by integrating all sponge-related functions into onefully automated unit. The present invention is different from prior arton the subject of sponge management in that it has the ability todistinguish between different types of sponges, maintain a running countof each type of sponge being used in a given procedure, andautomatically calculate the amount of blood contained in those sponges,instantly. These improvements will dramatically affect sponge managementin the areas of safety, sponge counts and blood measurement.

Safety: The present invention will have its biggest impact in the areaof increased safety for medical staff. Exposure to bloodborne pathogenswill be significantly reduced due to less handling of soiled sponges andthe closed environment of the device. Currently, soiled sponges arehandled several times by different members of the medical team. They arefirst handled by scrub personnel. Next they are counted by thecirculating nurse. They are then bagged, weighed when necessary, and ifa count is incorrect, they are removed from the bags and recounted.Finally, an orderly has to clean the area where the sponges are handled.With the present invention, soiled sponges will only be handled once bythe staff member who deposits the sponge into the device. The devicewill then do the counting, estimate blood loss amount and store thesponges in a disposable bag. This will be done in a closed environmentas opposed to an open bucket thereby reducing airborne contamination andalso reducing the time spent cleaning areas where sponges are counted.Because the disposable bag is enclosed inside of the device, lessbloodborne pathogens can escape due to evaporation.

Sponge Counts: The present invention will increase the accuracy ofsponge counts by eliminating human error and providing a running countof sponges already used. It will give a visible readout of all differenttypes of sponges used during a given procedure. This is importantbecause it allows the staff to constantly check counts throughout theprocedure. An increase in accuracy reduces the chances that a spongewill be left in a patient. This increases safety for the patient andreduces the time that is spent recounting sponges, thus reducing totalcount time. Also, because the device contains a disposable hag, staffwill no longer have to bag sponges manually, thus saving time. Thetechnology that is preferred to be used to do the scanning (radiofrequency) is extremely accurate.

Estimated Blood Loss Measurement: The present invention has the abilityto weigh soiled sponges, automatically compute blood loss, and give aconstant visible readout of that amount. This is an important featurefor several reasons. A constant readout is valuable to anesthesiologistsand surgeons who use this information as one component in estimatingtotal blood loss for a given procedure. Instant information is helpfulwhen ordering blood components and reduces guessing on blood lossamount. In the case of small children or infants this information iscritical. Currently, surgeons and anesthesiologists have to estimate theamount of blood loss by sight and the manual weighing of sponges, whichis done by the circulating nurse. Besides the time saved in weighing anddoing a manual calculation of blood loss, the device reduces human errorin the calculation. This increases safety for the patient. Also, areduction in time spent handling soiled sponges reduces staff exposureto blood.

The apparatus of the present invention counts surgical sponges (Laps,Raytecs, etc.) with a high degree of accuracy. It constantly calculatesthe amount of blood and other bodily fluids in the sponges. It includesa rechargeable battery 11 and can include a visible battery gauge whichdisplays the remaining life of the battery in hours. It has an alarmwhich goes off when the charge in the battery 11 drops below apredetermined amount. The battery 11 is rechargeable during operation ofdevice 30.

The container 30 of the present invention is compact in size, and canhave exemplary dimensions of one foot by two feet, which is bigger thana standard a kick bucket.

Container 30 is mobile and durable. It can distinguish between differenttypes of sponges (Laps, Raytec, Mini-Laps, etc.). It includes disposablebags. It is simple and easy to operate, and has the operatinginstructions on its face. Disposable bags 8 have a capacity of at leastforty sponges when properly installed upon bag container 21 of device30.

Container 30 can interrupt the count and maintain the sponge count andblood loss amount. An alarm sounds when it is time to change bag 8 (thatis, when a predetermined number of sponges have entered container 30since the last change of the bag). An alarm could also sound when aforeign object is present in the container 30.

The device 30 of the present invention can read tags 1 even when the tag1 is hidden or covered with blood. Device 30 is easily and quicklycleaned. It is water-resistant and does not have to be sterile.

The reader 6 can preferably detect up to fifty tags 1 at one time. Itpreferably can detect foreign objects, such as needles, hypodermicneedles, cottonoids, bovie tips, etc. The count can be interrupted toallow the inspection of foreign matter. The reader 6 could be in eitherlocation shown in FIG. 1, or in both locations if necessary to provide100% accuracy in detection.

The ability to distinguish between different types of sponges helps toaccurately estimate the amount of blood lost during surgery. Forexample, Raytec sponges weigh, when dry, about five grams. Lap spongesweigh, when dry, about 20 grams. When soaked with blood and/or otherbodily fluids, Raytec sponges can weigh up to about 50 grams and Lapsponges can weigh up to about 120 grams. Suppose, for example, thatforty sponges are used during an operation, and half are Raytec spongesand the other half are Lap sponges. The total weight of blood andsponges is about 1,500 grams, with 500 grams representing the dry weightof the sponges and 1,000 grams representing the weight of the blood andother bodily fluids (1,000 cc's of fluid). If all of the sponges weretreated as being Lap sponges, then the calculation would improperlytreat 300 grams of blood as dry weight of the sponges. Thus, the amountof estimated fluid lost would be improperly reduced by 300 grams (300cc's of blood). The weight of tags 1 is not being considered, since tags1 weigh the same whether attached to a Raytec sponge or to a Mini-lapsponge.

The preferred embodiment of the present invention is a hand-heldsurgical sponge detection system shown in FIGS. 7 and 8. A hand-held RFreader 40 will be used by surgeons 85 to detect the presence of surgicalsponges 2 in the body cavity at the time of closure during a surgicalprocedure (see FIG. 8). The Hand-held. RF reader 40 will be passed overthe surgical site 80 prior to the closing of the cavity by the surgeon85. It will then identify any sponges 2 which may have beeninadvertently left in the wound, thus preventing the retention ofsponges 2 inside of the patient. This hand-held RF reader 40 can be usedduring all surgical procedures and will eliminate the dangerous andtime-consuming task of manually counting and bagging of soiled sponges2. This device is small in size, (preferably smaller than 10 inches inlength×7 inches in Width×10 inches in Height, excluding the antenna 44),light-weight, (less than three pounds) and battery operated. It can beused alone or as part of the “Automatic Surgical Sponge Counter andBlood Loss Determination System” described in co-pending InternationalApplication Number PCT/US95/09094 and U.S. patent application Ser. No.08/286,413. The length L of antenna 44 is preferably one to 28 inches,more preferably five to 25 inches, and most preferably ten to 14 inches.Antenna 44 can be, for example, 14 inches long.

When a surgeon 85 is ready to begin closure of the body cavity, thehand-held RF reader 40 will be passed over the surgical site 80. A redlight 41 on the hand-held RF reader 40 indicates the presence of asponge 2 in the wound 81 and a green light 42 indicates that no sponges2 are in the wound 81. If a sponge 2 is detected, an optional LCDreadout 43 on the display can indicate what type of a sponge 2 is in thecavity (Laparotomy, Mini-Laparotomy, Raytec, etc.). Before the device 40is handed to the surgeon, it will be placed in a sterile plastic bag(not shown) to prevent blood from getting on the device 40. After thehand-held RF reader 40 is used, it will be removed from its protectivebag, cleaned and stored until its next use. If necessary, it may bepossible to sterilize the device 40. The hand-held RF reader 40 can bemounted on the wall in the operating room for easy accessibility or ifthe room has an automatic surgical sponge counter and blood lossdetermination system 30, it can be mounted on this device 30. A trigger45 is used to activate the reader 40.

There are several commercially available hand held readers on the markettoday which could be used with slight or no modifications. Thesemodifications could include a redesign of the handle to adjust for theergonomic demands of the operating room and if necessary, a redesign ofthe reader antenna to increase the read range of the reader. An exampleof a commercially available hand held reader which could be used is theTrovan®—Model LID 500 hand held reader which is manufactured byAEG/Telefunken. The invention disclosed herein can be demonstrated nowby using animal carcasses, veterinary surgery or by having a person layon top of an RF tag 1. The inventors have successfully demonstrated aread range of up to 12 inches through tissue using a LAN-LinkCorporation—Advanced Long Range Reader, an antenna with dimensions ofnine inches by nine inches and a variety of commercially available, readonly, 125 khz tags manufactured by Sokymat, SA of Switzerland andLAN-Link Corporation of St. Louis, Mo.

The hand-held RF reader 40 will totally eliminate the chance of asurgical sponge 2 being retained inside of a patient during surgery. Asa result, the labor intensive, dangerous, and error-ridden methodscurrently being used in operating rooms worldwide to account for soiledsurgical sponges will also be eliminated. By having the ability toautomatically identify these sponges 2 at any time during surgery,especially at the time of closure, an increased level of safety for bothpatients and staff will be realized, a drastic increase in theproductivity of nursing staff will occur, procedures will bestreamlined, and liability for hospitals, surgeons and nurses will bereduced. Sponges are the most time consuming and dangerous foreignbodies to keep track of during surgery as well as the item most oftenretained. The hand held RF reader 40 is particularly well suited fortrauma cases, thoracic and abdominal surgery.

The sponge management system (automatic surgical sponge counter andblood loss determination apparatus) 30 of the present invention is afully automated medical device which will manage all sponge-relatedfunctions in an operating room. This small, mobile unit 30 will handlethe counting of all sponges 2 used during surgery, regardless of thesize of those sponges 2. It will also bag, weigh and automaticallycompute the amount of blood contained in those sponges 2, instantly. Aliquid crystal display screen will display a readout in CC's ofestimated blood loss amount contained in the unit, as well as a runningcount of all types of sponges 2 deposited. The hand-held RF reader 40will be mounted on device 30, to be used at the time of closure toassure that no sponges 2 have been retained in the body cavity. Device30 is particularly well suited for procedures in which above-averageblood loss occurs such as cardiac, transplants, obstetrical, etc. andprocedures involving small children or infants where blood lossmonitoring is critical.

In the United States and many other industrialized nations worldwide,hospitals are facing tremendous pressure by both the public and privatesectors to reduce costs while at the same time delivering high qualitypatient care. Hospital administrators must begin looking at innovativeways to wring out excessive costs through the use of automation and jobredesign. Both of the devices discussed will give operating roommanagers the opportunity to significantly reduce costs by automating,streamlining and eliminating many of the dangerous and time consumingtasks currently involved in sponge management during surgicalprocedures. Significant productivity gains can be expected as theimplementation of RF technology reduces labor time and allows for a moreefficient utilization of staff and thus a reduction in payroll costs.Safety for both patients and staff will be significantly increased byeliminating the manual counting, bagging and weighing of soiled surgicalsponges 2. This dangerous, labor intensive task will be replaced by ahand-held RF reader 40 that will totally eliminate any chance of asponge 2 being retained in the patient. Sponges left in patient are oneof the leading causes of malpractice lawsuits and insurance claimsfollowing surgery. Blood exposure for medical staff will be drasticallyreduced by eliminating the handling of soiled sponges.

The Hand-held RF reader 40 and device 30 will improve productivity andhelp bring down labor costs. Labor costs account for 32% of the typicalsurgery department's budget. Current methods of sponge management relyon the manual counting, bagging and weighing of soiled surgical sponges.This task is almost always performed by a Registered Nurse because ofpatient safety and liability issues involved. In medium to heavy bloodloss cases, a significant amount of labor time is committed to thistask. For a two to three hour procedure such as a prostatectomy, twentyto thirty minutes of nurse labor is required to manually account for thefifty to sixty sponges utilized during the procedure. In larger casessuch as cardiac, transplants, vascular, abdominal, trauma, andobstetrical, for example, the amount of labor time is even greater. TheHand-held RF reader 40 will totally eliminate any counting of spongesregardless of procedure. Nurses will now have more time to chart and dopaperwork, prepare medications, order blood components, prepare for thenext case and be more attentive to the needs of the surgical team andpatient. Many surgery departments are currently trying to reduce theratio of expensive Registered Nurses to inexpensive unlicensed personnelon their staff. The hand-held RF reader 40 and device 30 will helphospitals facilitate this process by utilizing their RN staff moreefficiently by having RN circulators supervise less expensive unlicensedpersonnel in several rooms, simultaneously.

The hand-held RF reader 40 and device 30 will increase safety for bothpatients and medical staff. The Hand-held RF reader 40 will totallyeliminate the chance of a sponge 2 being retained in the patient anddevice 30 will improve the accuracy and availability of blood lossestimation in cases in which blood loss is significant or vital due tosize and age of patient. These devices will also eliminate the need forstaff to manually account for soiled sponges which exposes them toexcessive blood exposure and ergonomic hazards such as back injuries.

The main reason for the elaborate count procedures currently used inmodern operating rooms today is to prevent the retention of foreignobjects such as sponges, instruments, sutures, bovie tips, etc. in thebody cavity. Sponges in particular can cause severe infections andinjury if left in the patient. If a sponge is accidentally retained,then all relevant members of the team can be held responsible, eitherindividually or jointly. This includes the surgeon, the circulatingnurse and the hospital. Evidence of a retained sponge being left in apatient after closure is considered proof of negligence on the part ofthe medical team. From a liability standpoint, when a retained spongecase is brought to court, the question is not, “Who is responsible?” but“How much is the injury worth?” Retained sponge cases usually aresettled before court proceedings unless the plaintiff asks forunrealistic compensation.

Current methods for estimating blood loss in surgical sponges areinadequate because of excessive reliance on visual estimation and manualweighing of sponges. Currently, if a surgeon or anesthesiologist needsto know how much blood is contained in the sponges, he must estimate theamount by visual inspection of sponge bags. Although the individualphysician may know that he or she is in the safe zone, without actuallyweighing the sponges, they cannot know the exact amount. In manyinstances, blood contained in the sponges is the only exact amount ofblood loss that is unknown by physicians during surgery. In certainprocedures and in the case of infants and small children, it is vital toknow this amount. The surgeon may request that the circulating nursemanually weigh the sponges and calculate the amount of fluid containedin those sponges. When sponges are weighed, the circulating nurse mustindividually weigh each sponge before bagging and keep a running totalthroughout the procedure. This involves several manual calculations.This is very time consuming, prone to human error and involves excessivehandling of bloody sponges. Device 30 will improve blood loss estimationtechniques just discussed. It will have the ability to weigh sponges anddetermine blood loss contained in those sponges, instantly. This amountwill be displayed on a display panel for all staff to see. This isimportant for several reasons. Human error in the calculation is reducedby having the device perform the calculation instead of a busy nurse.All relevant data needed for the calculation is contained on the tag andpreprogrammed software in the device. The unit will use this informationalong with data from an internal scale to accurately determine bloodloss. A constant, visible readout of this amount may increase responsetime when ordering blood components. In addition, device 30 will reduceguessing by surgeons and anesthesiologists on blood loss amountcontained in the sponges 2. All of these improvements will increasepatient safety.

Safety for medical staff will also be improved by using the Hand-held RFreader 40 and device 30. Current methods are unsafe for a variety ofreasons. Exposure to blood is unacceptably high and back injuries arecommon. With the prevalence of Hepatitis B Virus (HBV), HumanImmunodeficiency Virus (HIV), and other dangerous pathogens in today'ssociety, blood exposure is one of the most pressing issues in theoperating room today. Currently, soiled sponges are handled severaltimes by different members of the medical team. They are first handledby scrub personnel. Next they are manually counted by the circulatingnurse. They are then bagged, weighed when necessary, and if a count isincorrect, they are removed from the bags and recounted. Finally, anorderly has to clean the area where the sponges are handled. If it is along procedure, shift changes or relief breaks can expose morepersonnel. With the hand-held RF reader 40 and device 30, blood exposurefor the circulating nurse will be dramatically reduced. The circulatorwill no longer have to touch bloody sponges. Instead of several staffmembers handling sponges, the number is reduced to one. Regardless ofwhich device the operating room is using, the scrub person will be theonly staff member who will come in contact with soiled sponges. In roomswhere both the Hand-held RF reader 40 and device 30 are being usedtogether, the scrub will deposit sponges 2 directly into device 30. Theunit will then count, bag, weigh and calculate blood loss. Ninetypercent of blood exposure that a circulating nurse currently encounterson a daily basis comes from handling sponges. The number of staff whoseblood exposure will be reduced is amplified when the people involved inshift changes and relief crews are included. The standard kickbucket,into which the used sponges are deposited now, is basically a stainlesssteel bucket with wheels. As the blood in the sponges evaporate,airborne contamination can occur. This is not sanitary, nor safe. Device30 will store the sponges 2 inside the device in a removable disposablebag. This is a closed environment as opposed to the open environment ofthe kickbucket. In addition, nurses are constantly bending over toretrieve sponges from this bucket. This is not ergonomically sound andleads to numerous back injuries. Nurses rank fifth among occupationsreceiving worker's compensation claims for back injuries. These backinjuries average $3,000 to $4,000 per reported injury. If a procedureuses fifty sponges, the circulating nurse will have bent over anywherefrom five to fifty times in order to retrieve the sponges. In largecases, sometimes the nurse will get on her hands and knees and layoutsoiled sponges on the floor to get an accurate count. Device 30 willeliminate the need to bend over in order to retrieve sponges out ofkickbuckets and thus will reduce the number of back injuries in theoperating room. Kickbuckets will no longer be necessary in operatingrooms. This should reduce the number of personnel who injure themselvesby tripping over them. In conclusion, device 30 and hand-held RF reader40 will provide a safer operating room environment for medical staff.

Repeat surgeries to extract retained sponges will be eliminated and allassociated surgery costs will be as well. X-ray costs will be reduced asthey will not be needed anymore to determine if a sponge has beenretained. Typically it cost around sixty dollars for one of theseoperating room X-rays to be taken. This does not take into account thefifteen to thirty minutes of valuable room time which is needed, theprotection measures such as lead aprons, etc. that the staff must takeand the x-ray exposure to which the patient is exposed.

The following are advantages that key personnel and hospitals whoutilize the present invention will realize.

For nurses, the invention: reduces or eliminates count time; can reduceliability with respect to retained sponges; reduces exposure to blood;reduces risk of infectious disease; increases accuracy of count;increases patient contact; increases attentiveness to procedure;increases attentiveness to surgeon's needs; increases attentiveness toanesthesiologist's needs; increases attentiveness to surgical tech'sneeds; and increases productivity by freeing the nurse for other duties.

The surgeons and anesthesiologists benefit because the presentinvention: increases accuracy of blood loss amount; can reduce liabilitywith respect to retained sponges; increases response time on checkingand ordering blood components; and reduces guessing on blood lossamount.

The hospital benefits from the present invention because: it helps toprovide a safer environment for operating room employees due to lessexposure to bloody sponges; it increases accuracy of sponge counts; whenthe hand-held reader is used, it can eliminate the need to countsponges; it causes a reduction in or elimination of repeat surgeries toextract sponges left in wounds; it causes a reduction in costs and risksassociated with repeat surgeries; it causes an increase in productivityof the Circulating Nurse; it causes an increase in quality of patientcare due to more attentive O.R. Nurse, less chance of repeat surgery dueto sponge left in wound, and reduced guessing on blood loss byanesthesiologists.

While it is preferred to use radio frequency tags and an associateddetector, other means for distinguishing one type of sponge from anothercould be used, such as an electric eye, metal indicators, colorindicators. However, tags which can be detected by non-optical detectingmeans are preferred, because then one does not need to be concernedabout the location of the tag and whether it is clean or covered withblood.

The RF tags 1 used for the present invention are preferably inexpensive,small, durable, extremely accurate and reliable with a read range of atleast ten inches. The tags 1 will be fastened to the sponges 2 when thesponges 2 are being manufactured.

The tags 1 should be small so that they are unobstructive to the surgeonand easily attached at the factory. Several manufacturers have suitabletags which have diameters of less than a half inch and weigh less than 4grams. Three possible means for attachment include; sewing the tag intothe sponge, gluing and pressing between layers of material, riveting thetag onto the sponge or a combination of these methods. Any method ormethods utilized must be extremely secure to avoid a tag 1 being left ina patient. The tags 1 will be attached to all types and sizes ofsurgical sponges used during surgery. This includes Laparotomy,Mini-Laparotomy, Raytec, etc. So that the sponges 2 are compatible withthe device 30, each different type of sponge 2 will have a unique codewhich identifies the size and type of sponge 2 being tagged (aLaparotomy sponge for example).

The tags 1 must be durable to withstand the unique rigors of theoperating room environment. Currently available tags can withstand allsterilization processes used to sterilize sponges. Examples include:gamma radiation, gas concentration, vacuum, pressure and temperature.They can withstand temperatures up to 400° F. without affecting internalcomponents.

RF tag technology is extremely accurate and reliable. As long as the tagis within the appropriate read range of the reader, a proper scan willoccur. An appropriate read range required of this application for mostpatients is eight to fifteen inches. Several manufacturers currentlyhave appropriate tags and readers which meet this criteria.

The preferred frequency is between 100 khz and 150 khz or between 10 mhzand 20 mhz. These frequencies have been proven to operate effectivelythrough water and tissue.

Tags which could advantageously be used as tag 1 are the Sokymat, SA,PICCOLO-TAG. This RFID tag has a operating frequency of 125 khz, 64 bitsof memory, diameter of 10 mm and thickness of 2 mm. Sokymat also hasseveral other models of 125 khz tags of various encapsulations(polyester, glass) and sizes which are appropriate for this application.The inventors have tested these Sokymat, SA RFID tags using the LAN-LinkCorporation ALR reader and a nine inch by nine inch customized antenna.A read range of up to twelve inches was obtained through human tissue.Other companies which manufacture appropriate tags are Trovan®Electronic Identification Systems and Texas Instruments-TIRIS.

Preferably, reader 6 is a reader which can detect and distinguish amongand identify multiple sponges simultaneously, such as or similar tocommercially available readers available from Samsys Technologies ofOntario, Canada and or LanLink Corporation of St. Louis, Mo. In thismanner, even if two or more sponges are deposited into the receptacle atthe same time, they will be properly detected and identified.

Preferably, reader 40 is a reader which can detect and distinguish amongand identify multiple sponges simultaneously, such as or similar tocommercially available readers available from Samsys Technologies ofOntario, Canada and or LanLink Corporation of St. Louis, Mo. In thismanner, even if two or more sponges are present in a patient, they willbe properly detected, identified and removed.

With a reader having a large enough read range and the ability to readmultiple tags simultaneously, it would be possible to put a scanner onthe bottom of the container and or adjacent to the container andconstantly read all tags in the bag. Using an “anti-collision” or“anti-clash” protocol, each tag transmits its data and then waits aperiod of time before repeating its message. Statistics dictate thateach tag eventually transmits when no other tags are transmitting andits data is read.

All measurements disclosed herein are at standard temperature andpressure, at sea level on Earth, unless indicated otherwise. Allmaterials used or intended to be used in a human being arebiocompatible, unless indicated otherwise. Also, the frequencies usedare preferably biocompatible.

The foregoing embodiments are presented by way of example only; thescope of the present invention is to be limited only by the followingclaims.

What is claimed is:
 1. An automatic sponge counter apparatus forcounting sponges, each sponge carrying an RF identification tag operableto transmit a unique data string corresponding to the tagged sponge, theapparatus comprising: a non-optical scanner configured to interrogate aplurality of RF identification tagged sponges simultaneously presentwithin a volume, said scanner simultaneously reading a plurality oftagged sponges present within said volume, said scanner detecting eachof the plurality of tagged sponges electromagnetically, said scannerdetecting the unique data strings corresponding to each of the pluralityof tagged sponges; and a control unit that maintains a count of a totalnumber of tagged sponges present in said volume, said control unitmaintaining a running count of a number of tagged sponges from apredetermined time, said control unit being responsive to saidnon-optical scanner, said control unit receiving the unique data stringsfrom the non-optical scanner, said control unit identifying each of theplurality of tagged sponges based on the unique data string.
 2. Theapparatus of claim 1, further comprising a handheld scanner.
 3. Theapparatus of claim 1, wherein an RF tag attached to one of the taggedsponges is encoded with a number selected from within a range of 0 to 64bits, binary.
 4. The apparatus of claim 1, wherein the scannerinterrogates tagged sponges placed in a container having only a singleaccess opening therein.
 5. The apparatus of claim 1, wherein the scannerinterrogates the plurality of tagged sponges using a plurality ofantennas.
 6. The apparatus of claim 5, wherein the plurality of antennasincludes at least three antennas positioned orthogonally.
 7. An methodfor counting sponges, each sponge carrying an RF identification tagoperable to transmit a unique data string corresponding to the taggedsponge, the method comprising: interrogating a plurality of RFidentification tagged sponges simultaneously present within a volumeusing a non-optical scanner, said interrogating simultaneously reading aplurality of tagged sponges present within said volume, saidinterrogating detecting each of the plurality of tagged spongeselectromagnetically, said interrogating detecting the unique datastrings corresponding to each of the plurality of tagged sponges; andmaintaining a count of a total number of tagged sponges present in saidvolume, said maintaining a count maintaining a running count of a numberof tagged sponges from a predetermined time, said maintaining a countincluding: receiving the unique data strings from the non-opticalscanner, and identifying each of the plurality of tagged sponges basedon the unique data string.
 8. The method of claim 7, wherein one of thetagged sponges is interrogated using a handheld scanner.
 9. The methodof claim 7, wherein an RF tag attached to one of the tagged sponges isencoded with a number selected from within a range of 0 to 64 bits,binary.
 10. The method of claim 7, wherein the scanner interrogatestagged sponges placed in a container having only a single access openingtherein.
 11. The method of claim 7, wherein the scanner interrogates theplurality of tagged sponges using a plurality of antennas.
 12. Themethod of claim 11, wherein the plurality of antennas includes at leastthree antennas positioned orthogonally.
 13. A RF identification taggedsurgical sponge configured for automatic counting, comprising: anabsorbent material; an RF identification tag attached to the absorbentmaterial; the RF identification tag being operable to transmit a uniquedata string corresponding to the tagged sponge; the tagged sponge beingconfigured for being detected using a non-optical scanner thatinterrogates a plurality of RF identification tagged spongessimultaneously present within a volume, said interrogatingsimultaneously reading a plurality of tagged sponges present within saidvolume, said interrogating detecting each of the plurality of taggedsponges electromagnetically, said interrogating detecting the uniquedata strings corresponding to each of the plurality of tagged sponges;wherein the non-optical scanner maintains a count of a total number oftagged sponges present in said volume, said maintaining a countmaintaining a running count of a number of tagged sponges from apredetermined time, said maintaining a count including: receiving theunique data strings from the non-optical scanner, and identifying eachof the plurality of tagged sponges based on the unique data string. 14.The sponge of claim 13, wherein the tagged sponge is configured to beinterrogated using a handheld scanner.
 15. The sponge of claim 13,wherein an RF tag is encoded with a number selected from within a rangeof 0 to 64 bits, binary.
 16. The sponge of claim 13, wherein the scannerinterrogates tagged sponges placed in a container having only a singleaccess opening therein.
 17. The sponge of claim 13, wherein the scannerinterrogates tagged sponges using a plurality of antennas.
 18. Thesponge of claim 17, wherein the plurality of antennas includes at leastthree antennas positioned orthogonally.
 19. The sponge of claim 13,wherein the tag indicates a dry weight of the sponge.
 20. The sponge ofclaim 13, wherein the tag does not exceed one inch in diameter and 0.20inches in thickness.
 21. The sponge of claim 13, wherein the tag doesnot exceed three grams in weight.